EasiVENT Valved Holding Chamber - Easivent Valved Holding Chamber is designed to - Mylan Specialty L.P.

Duns Number:194775557

Device Description: Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler (MDI) aero Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler (MDI) aerosol medication delivery. It is comprised of a MDI adapter port, Holding chamber, a one way valve, Mouth Piece and mouthpiece cap

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More Product Details

Catalog Number

-

Brand Name

EasiVENT Valved Holding Chamber

Version/Model Number

49502-207

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

8ff4e971-7aa1-4a5c-9f86-d0bc7a61c5fd

Public Version Date

January 21, 2022

Public Version Number

3

DI Record Publish Date

April 10, 2018

Additional Identifiers

Package DI Number

30349502207014

Quantity per Package

12

Contains DI Package

00349502207013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MYLAN SPECIALTY L.P." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2